Duns Number:080935429
Device Description: Chemotherapy Patient Examination Gloves 8 mil, Nitrile, Powder-free, Small
Catalog Number
CTS731S
Brand Name
ChemoPlus
Version/Model Number
CTS731S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
520583b7-fff7-43fb-ba80-463af001a135
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 28, 2018
Package DI Number
20884521132570
Quantity per Package
200
Contains DI Package
10884521132573
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |